FDA May Act on Ephedra Substitutes, Others

It's time for supplement companies and consumers to hit back. IMO this is the beginning of the end unless something is done.

FDA May Act on Ephedra Substitutes, Others

Mon Apr 19, 6:13 PM ET Add Health - Reuters to My Yahoo!

By Susan Heavey

WASHINGTON (Reuters) - The U.S. Food and Drug Administration (news - web sites) is gathering evidence on the safety of several alternatives to ephedra, the weight-loss herb the agency banned a week ago, the agency's top official said on Monday.

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Acting FDA Commissioner Lester Crawford said regulators are also compiling data on three other supplements, including kava, a dried root often used as a relaxant that has been linked to liver damage.

"Never again will one of these (supplements) as bad as ephedra take two years" to ban, Crawford said.

The FDA is collecting research results, reports of health problems and other information to help officials decide whether to ban other supplements, he said.

"We've started the clock ticking. Maybe it will result in an ephedra-like decision for some of these (or) maybe not" Crawford said in a speech to the American Society for Pharmacology and Experimental Therapeutics in Washington.

Since the agency announced the ephedra ban last December, a number of manufacturers have sought to fill the void with other products, including so-called bitter orange, or Citrus aurantium. The ban took effect last Monday.

Bitter orange contains several substances that produce an ephedra-like stimulation and have been shown to increase blood pressure. But Crawford said it was "too soon to say" whether it should be removed from the market.

While there are similarities, "the concerns are being overblown," said Michael McGuffun, president of the American Herbal Products Association. Many products put forward to replace ephedra are caffeine-based, he said.

The FDA is also compiling data on usnic acid, Crawford said. The lichen-produced chemical is used in some products touting weight control and has been linked to liver damage.

Pyrrolizidine alkaloids, compounds found in plants, can be toxic and are also under review, he said.

While most supplements "are probably safe" when used correctly, the industry's diversity and ability to quickly devise new products make it difficult to regulate, Crawford said.

But the recent ephedra court ruling favoring the FDA gave the agency strength to act against other supplements in the future, Crawford added.

The Council for Responsible Nutrition, a supplement industry group, supports FDA's safety efforts, President Annette Dickinson said, adding that many companies have already placed warnings on kava products.

The FDA last month recommended that the National Institutes of Health (news - web sites) make studying these four supplements a priority.

Paul Coates, head of NIH's Office of Dietary Supplements, said the institute's ephedra studies put steps in place to evaluate similar products but would not say if any studies were planned.

EWARK, April 12 — A federal judge here cleared the way on Monday for a ban on the sale or manufacture of ephedra to start immediately.

The judge denied a request by two manufacturers of the dietary supplement to delay the ban pending the outcome of a lawsuit. The manufacturers have sued the Food and Drug Administration and the Department of Health and Human Services.

Judge Joel A. Pisano of United States District Court ruled that NVE Pharmaceuticals of Andover, N.J., manufacturer of Stacker 2, and the National Institute for Clinical Weight Loss of Birmingham, Ala., manufacturer of Thermalean, had not met the standards for a temporary restraining order.

In a briefing, the F.D.A. said that the ban was in place and that it was investigating whether manufacturers or retail outlets were violating the law by continuing to sell ephedra. An assistant commissioner, Jeffrey Shuren, said the agency would be able to enforce the ban.

"Right now," Mr. Shuren said, "we think we have the people we need to get the job done. This is really going to be a test case."

A lawyer for NVE, Walter P. Timpone, said he was disappointed with the ruling on Monday.

Timothy M. Fulmer, a lawyer for the weight loss institute, said of the manufacturer, "If this rule goes forward as of today, they will have no product."

Senator Richard J. Durbin, Democrat of Illinois, had said the agency was too understaffed to monitor a multibillion-dollar industry effectively.

For a restraining order, Judge Pisano would have had to find that the manufacturers' case had a strong likelihood of prevailing, that they would suffer irreparable harm and that the public interest would be served. He ruled against the companies on all three points.

"Virtually every fact in this case is disputed," Judge Pisano said.

He added that the number of documents submitted in the case — the Food and Drug Administration submitted 133,000 pages — made it impossible for him to decide which side was likely to prevail.

"The resolution of the findings in this case is going to require a full evidentiary hearing and a full review of the administrative record," Judge Pisano said.

He noted that the agency had received 18,000 reports of harm associated with ephedra, including 164 deaths.

Barbara J. Michal, founder of an advocacy group Halt Ephedrine Abuse Today, said she was thrilled by the decision. Ms. Michal's son Kristopher died seven years ago, after taking ephedrine, the active ingredient in ephedra.

"Every day ephedra stays on the market," she said, "is another potential body bag."

I think the second article is a perfect example of what's wrong with the mainstream media. Starting with the most obvious

Barbara J. Michal, founder of an advocacy group Halt Ephedrine Abuse Today, said she was thrilled by the decision. Ms. Michal's son Kristopher died seven years ago, after taking ephedrine, the active ingredient in ephedra.
"Every day ephedra stays on the market," she said, "is another potential body bag."

First of all what Barbara Michal said is a hell of a accusation against ephedra. Did they give the supplement companies a chance to respond to that charge? Hell No! Look who they gave the last word to and what the last words of the story are........."Every day ephedra stays on the market," she said, "is another potential body bag." Is someone who doesn't know allot about the subject going to have a fair and good grasp of the pros and cons of ephedra use after reading the last words of the story?
The beginning states how the judge ruled against them and the end leaves the reader with the idea the this stuff will kill you. If the supplement companies point of view was represented it was sporadically buried in the middle of the story.
Notice they didn't say how much her son was taking. Did he take the whole bottle? Was he competing in a sport not eating or drinking any fluid to make a weight class and exercising for long periods of time in extreme heat and humidity.Absolutely no information is given.

He noted that the agency had received 18,000 reports of harm associated with ephedra, including 164 deaths.

Here they didn't give an estimated number of people take ephedra which I believe is in the millions. They also fail to mention if the people who had adverse reactions to it took over the recommended dose. They also failed to mention what the FDA's standards for drug safety is. If you use 1 mil for the number of people using it you get a 1.8% chance of an adverse reaction and the chances of death are .0166%. In other words you have a 98% chance of having no adverse reaction to ephedra and less than 1 % chance of dieing from it. The numbers would be even less if you take into account of the people who pop them like a vitamin C.

Senator Richard J. Durbin, Democrat of Illinois, had said the agency was too understaffed to monitor a multibillion-dollar industry effectively.

Translation- the government should step in and take control of the supplement industry.

For a restraining order, Judge Pisano would have had to find that the manufacturers' case had a strong likelihood of prevailing, that they would suffer irreparable harm and that the public interest would be served. He ruled against the companies on all three points.